Evidence map›Paper›PMID 31240995›Full record

Trial reportTherapeutic advances in respiratory disease

The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China.

Kewu Huang, Yanfei Guo, Jian Kang, Li An, Zeguang Zheng, Lijun Ma, Liping Peng, Hongyang Wang, Rong Su, Yohji Itoh and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01415518 (Efficacy and Tolerability Study of Symbicort Turbuhaler), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01415518 phase4completednot on this map

Efficacy and Tolerability Study of Symbicort Turbuhaler(160/4.5µg/Inhalation,2inhalations Twice Daily) Added to Atrovent (20µg/Inhalation, 2 Inhalations 4 Times Daily)+Theophylline SR(0.1g/Tablet,1 Tablet p.o. Twice Daily) Compared With Atrovent+Theophylline SR in Severe COPD Patients.

TypeinterventionalSponsorAstraZenecaRan2011 to 2012Enrolled581ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsDrug: Budesonide/formoterol (Symbicort Turbuhaler, Drug: ipratropium (AtroventTM), theophylline SR
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 9 institutions in 2 countries.

Kewu HuangDepartment of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, China.
Yanfei GuoDepartment of Pulmonary and Critical Care Medicine, Beijing Hospital, Ministry of Health, Dongdan, China.
Jian KangThe First Hospital of China Medical University, Heping, Shenyang, China.
Li AnDepartment of Pulmonary and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
Zeguang ZhengThe First Affiliated Hospital of Guangzhou Medical University, Yuexiu, China.
Lijun MaHenan Provincial People's Hospital, Zhengzhou, China.
Liping PengJilin University First Hospital, Changchun, China.
Hongyang WangHebei United University Affiliated Hospital, Tangshan, China.
Rong SuGlobal Medicines Development, AstraZeneca, Shanghai, China.
Yohji ItohBiometrics, AstraZeneca, Osaka, Japan.
Chen WangDepartment of Pulmonary and Critical Care Medicine, Beijing Hospital, China.ORCID 0000-0001-7857-5435
Capital Medical University · CNAstraZeneca (Japan) · JPBeijing Hospital · CNFirst Affiliated Hospital of Guangzhou Medical University · CNFirst Hospital of China Medical University · CNHenan Provincial People's Hospital · CNJilin University · CNNorth China University of Science and Technology · CNShanghai Innovative Research Center of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients diagnosed with chronic obstructive pulmonary disease (COPD) in China are commonly prescribed ipratropium plus theophylline (I+T) therapy. Studies have shown that an inhaled corticosteroid (ICS)/long-acting β

methodsA randomized, parallel-group, open-label, multicenter phase IV study (Clinical Trials.gov identifier: NCT01415518) was conducted in China. Patients received either BUD/FORM (160/4.5 µg; two inhalations twice daily [bid] via Turbuhaler

resultsA total of 584 patients were randomized equally between treatment groups. At the end of the study, the BUD/FORM plus I+T group displayed significant improvements in predose FEV

conclusionPatients with severe COPD in China treated with BUD/FORM plus I+T showed significant improvements in lung function and HRQoL and a reduction in exacerbations compared with I+T alone. Both treatments were well tolerated and no safety concerns were noted.

Indexed as

AgedBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationChinaFemaleForced Expiratory VolumeHumansIpratropiumMaleMiddle AgedPulmonary Disease, Chronic ObstructiveQuality of LifeSeverity of Illness IndexTheophyllineTreatment OutcomeBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationIpratropiumTheophyllineantimuscarinicbudesonideCOPDformoterolglucocorticoidmethylxanthine

Identifiers

PMID31240995
PMCPMC6595664
OpenAlexW2953548211

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.